NCT01364935

Brief Summary

Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

3.2 years

First QC Date

May 31, 2011

Last Update Submit

June 24, 2014

Conditions

Infertility

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female participants trying to conceive, with regular menstrual cycles.

You may qualify if:

  • Participant is willing and able to give informed consent for participation
  • Females aged 18 to 44 years
  • Have a body mass index (BMI) above 19 and below 29
  • Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
  • Minimum menstrual cycle 24 days
  • Maximum menstrual cycle 33 days
  • Female participants willing to use the 3 fertility monitors for at least 3 cycles.
  • Willing to fill in regular questionnaires and study diaries

You may not qualify if:

  • Women aged younger than 18 years, or older than 44 years
  • Have a BMI less than 18 or greater than 29
  • Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
  • Polycystic ovary disease
  • Endometriosis or other pelvic pathology (including proven tubal disease)
  • Taking steroids, including oral contraceptives or anti inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Basil Matta

    Cambridge University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 3, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations

GB(1)